ImportRefusal LogoImportRefusal

Pocono Coated Products LLC.

⚠️ Moderate Risk

FEI: 3011029136 • Cherryville, NC • UNITED STATES

FEI

FEI Number

3011029136

📍

Location

Cherryville, NC

🇺🇸
🏢

Address

100 Sweetree St, , Cherryville, NC, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
10/31/2019
Latest Refusal
10/31/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/31/2019
66VBD99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pocono Coated Products LLC.'s FDA import refusal history?

Pocono Coated Products LLC. (FEI: 3011029136) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2019 to 10/31/2019.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Pocono Coated Products LLC.'s FEI number is 3011029136.

What types of violations has Pocono Coated Products LLC. received?

Pocono Coated Products LLC. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Pocono Coated Products LLC. come from?

All FDA import refusal data for Pocono Coated Products LLC. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.